Skip to content

Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy

Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02593942
Enrollment
80
Registered
2015-11-02
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2015-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Neoplasms

Brief summary

Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today. The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.

Detailed description

Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.

Interventions

DRUGRemifentanil

0.1-0.5 mcg/kg/min infusion

DRUGPropofol

75-200 mcg/kg/min infusion

Sponsors

Yeditepe University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anaesthesiologist physical status I-II * Glasgow Coma Scale score of 15 points * Elective supratentorial craniotomy for tumor resection * Supine position

Exclusion criteria

* Obese patient * Brain tumor greater than 30 mm in diameter * Postoperative cranial drainage * Hypertension * Diabetes mellitus * Reoperation * Pregnant * Breast feeding * Allergy to the study medications * History of cranial radiotherapy * Frontal bone flap * Intraoperative neuromonitoring

Design outcomes

Primary

MeasureTime frameDescription
Time of extubation3 hoursAfter the surgery, starting from three-pin head holder removal, an investigator asked each patient to open his or her eyes, squeeze the investigator's hand. When the patient opened his or her eyes, obeyed commands, resumed adequate respiration, hemodynamically stable and bispectral index spectrum \> 70-80 was extubated, and the time will be recorded. The patients will be followed for an expected average of 3 hours.

Secondary

MeasureTime frameDescription
Heart Rate6 hoursHeart rate per minute was recorded
Mean arterial pressure were recorded6 hoursMean arterial pressure (mmHg) was recorded
Post-anesthesia awaking time3 hoursPost-anesthesia awaking time assessed as the interval (min:sec)required to

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026